Article(id=1236344971020791898, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1665504000000, acceptedDateStr=2022-10-12, onlineDate=1772697211270, onlineDateStr=2026-03-05, pubDate=1678809600000, pubDateStr=2023-03-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772697211270, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772697211270, creator=13701087609, updateTime=1772697211270, updator=13701087609, issue=Issue{id=1236344966058931117, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='5', pageStart='441', pageEnd='552', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772697210087, creator=13701087609, updateTime=1772697640190, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236346770087793082, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236346770087793083, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=481, endPage=491, ext={EN=ArticleExt(id=1236344971243090015, articleId=1236344971020791898, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Toxicity studies of benvitimod after single dose administration and repeated dose administration, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To observe the single dose toxicity and repeated dose toxicity of benvitimod, and to provide evidence for clinical administration and drug safety.
Methods: Single dose toxicity: The animals were given benvitimod 2 000 mg·kg-1 (mice) or 500 mg·kg-1 (rabbits) by subcutaneous injection. After administration, the animals were continuously observed for 14~15 days, and the toxic reaction and deaths were recorded. Repeated dose toxicity: benvitimod was administered subcutaneously to rats at doses of 40, 100, and 200 mg·kg-1·d-1 and to rabbits at doses of 30, 60, 150 mg·kg-1·d-1 for 6 months and observed for 1 month after the end of administration. The general conditions of the experimental animals were observed daily, and the body weight and food intake of the experimental animals were measured weekly. Twenty-four hours after the last administration, 50% of the animals (male and female) in each group were taken for hematology, blood biochemistry and pathology examination. The remaining animals were discontinued for 1 month, and the corresponding indexes were checked as before.
Results: In the study of single dose toxicity, the NOAEL dose of benvitimod was 2 000 mg·kg-1 on mice and 500 mg·kg-1 on rabbit. In the study of repeated dose toxicity, after 6 months of subcutaneous injection, the NOAEL dose of benvitimod was 200 mg·kg-1 on rats and 150 mg·kg-1 on rabbit.
Conclusion: The results indicated that benvitimod had good safety in the clinical dosage.
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目的： 观察皮下注射给予本维莫德的单次给药和重复给药毒性反应，为临床安全用药提供依据。
方法： 单次给药毒性研究通过皮下注射方式一次性给予受试动物本维莫德2 000 mg·kg-1（小鼠）或500 mg·kg-1（家兔），给药后连续观察14~15 d，记录受试动物毒性反应及死亡情况。重复给药毒性研究通过皮下注射方式给予本维莫德40，100，200 mg·kg-1·d-1（大鼠）或30，60，150 mg·kg-1·d-1（家兔），连续注射6个月，给药结束后观察1个月。每日观察实验动物一般情况，每周测量实验动物体重及摄食量，末次给药终止后24 h，每组取50%受试动物（雌雄各半）进行血液生化学及病理学检查。剩余受试动物停药1个月，同前完成相应指标检查。
结果： 小鼠单次给药的无可见有害作用水平（no observed adverse effect level, NOAEL）剂量为2 000 mg·kg-1，家兔单次给药的NOAEL剂量为500 mg·kg-1。大鼠6个月重复给药的NOAEL剂量为200 mg·kg-1，家兔6个月重复给药的NOAEL剂量为150 mg·kg-1。
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, authorsList=孙丽, 李健雄, 刘全海, 刘珉宇)}, authors=[Author(id=1236344972035813495, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236344971020791898, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=sunli19860616@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236344972119699578, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236344971020791898, authorId=1236344972035813495, language=EN, stringName=Li SUN, firstName=Li, middleName=null, lastName=SUN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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